NICE positive FAD recommends STELARA® for ulcerative colitis

Apr 28, 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson welcomes the National Institute for Health and Care Excellence (NICE) positive Final Appraisal Document (FAD) recommending STELARA®(ustekinumab) as an option for treating moderately to severely active ulcerative colitis (UC) in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if:

  • a tumour necrosis factor (TNF)-alpha inhibitor has failed (that is the disease has responded inadequately or has lost response to treatment)
  • OR a TNF-alpha inhibitor cannot be tolerated or is not suitable.

UC is a chronic immune-mediated inflammatory disease of the rectum and large intestine, affecting approximately 146,000 people in the UK, for which there is currently no cure. For up to one-third of people with UC, current treatments are not completely successful or complications may arise, where surgery may be considered.

We are delighted that NICE revisited its decision and will now recommend ustekinumab for use in ulcerative colitis, as it is in Crohn’s disease. The impact of uncontrolled symptoms of ulcerative colitis can be devastating and debilitating. Current treatments simply do not work for everyone, so having as many treatment options as possible available, and allowing doctors and other clinicians to personalise their approach, is critical,” commented Sarah Berry, Health Service Project Manager, Crohn’s & Colitis UK*.

Ustekinumab is the first biologic therapy for UC that targets interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses, offering clinicians and patients a new mechanism of action for treating UC.

“Ulcerative colitis can have a devastating impact on the lives of those living with this long-term condition. A flare up of symptoms can be incredibly debilitating, preventing people getting on with normal day-to-day life and work. Many patients do not respond to, or get side effects from, currently available therapies. Therefore, the recent NICE approval for ustekinumab as a novel therapy for patients that are not suited to currently available treatments is welcome,” commented Professor James Lindsay, Consultant Gastroenterologist, Barts Health NHS Trust, London.

The NICE guidance is based on data from the pivotal Phase 3 UNIFI trial programme which evaluated ustekinumab’s safety and efficacy as a treatment option for adult patients with moderately to severely active UC. The programme was split into an initial Induction study (UNIFI-I) of eight weeks, followed by a Maintenance study (UNIFI-M) of 44 weeks. All patients who were randomised into the 44-week Maintenance study were induction responders to IV ustekinumab. Among patients subsequently randomised to receive subcutaneous ustekinumab (q8w or q12w), a significantly greater percentage achieved clinical remission at week 44 vs initial responders randomised to placebo (44 percent and 38 percent, vs 24 percent, p<0.001 and p=0.002, respectively).

Jennifer Lee, EMEA Therapy Area Market Access Lead for Immunology, Janssen-Cilag Limited, commented “We are pleased with NICE’s decision to accept ustekinumab for use within NHS England and Wales for eligible patients living with ulcerative colitis when either a TNF-alpha inhibitor is not appropriate or has not been effective. We have a long-standing commitment to developing innovative therapies to improve the lives of those living with immune-mediated inflammatory diseases. The decision from NICE reflects the true patient and clinical need for new treatment options for patients living with moderately to severely active ulcerative colitis.”

Ustekinumab is already recommended by NICE as a clinical and cost-effective option for the treatment of plaque psoriasis, psoriatic arthritis and CD.